Title
Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy
A Prospective Phase 1 Trial of Cardiac Progenitor Cell Therapy in Children With Dilated Cardiomyopathy
Phase
Phase 1Lead Sponsor
Okayama UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Dilated CardiomyopathyIntervention/Treatment
cardiac stem cells ...Study Participants
5A phase 1 prospective study to determine the procedural feasibility and safety and preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in patients with dilated cardiomyopathy.
Five consecutive patients will be enrolled to a phase 1 study to verify the procedural feasibility and safety with the CDC infusion group.
Injection of CDCs (0.3 million per kg of body weight).
Inclusion Criteria: Patients diagnosed as dilated cardiomyopathy. Patients aged under 18 years old. Cardiac ejection fraction < 40%. Exclusion Criteria: Contradiction to cardiac magnetic resonance imaging. Cardiogenic shock. A patient with unstoppable extracorporeal circulation. A patient with lethal, uncontrollable arrhythmia. A patient with a complication of coronary artery disease. A patient with a complication of brain dysfunction due to circulatory failure. A patient with malignant neoplasm. A patient with a complication of a serious neurologic disorder. A patient with high-grade pulmonary embolism or pulmonary hypertension. A patient with high-grade renal failure. A patient with multiple organ failure. Active infection (including endocarditis). Sepsis. Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury).
| Event Type | Organ System | Event Term | CDC Infusion |
|---|
Assessment of major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, acute coronary syndrome, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards.
To determine the changes in cardiac function by ejection fraction with cardiac MRI evaluation in CDC-treated participants from baseline to 6 months of follow up.
